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Tuesday, May 26, 2015

Verax Gains FDA Clearance for the Rapid Detection of Bacterial Contaminants in Platelets Intended for Transfusion

Verax Biomedical today announced that the company has gained FDA clearance to expand the use of its Verax Platelet PGD® test—a rapid test for the detection of bacterial contamination in platelets intended for transfusion. The new FDA clearance makes the Verax Platelet PGD test the only rapid test on the market cleared by the FDA to check every commonly distributed platelet type in the United States.

"Bacterial contamination of platelets is the number one infectious risk to transfusion recipients, and this FDA clearance makes the Verax Platelet PGD test the industry standard when it comes to the detection of bacteria in platelets," said Verax Biomedical CEO Jim Lousararian. "We applaud FDA for taking this critical step to help ensure patient safety and we look forward to continuing to work with the Agency, the transfusion community and other health care stakeholders to combat the severe risk of bacterial contamination in the U.S. blood supply."

Annually, more than 6 million platelet doses are transfused worldwide, and approximately 1 in 2,000 doses are contaminated by bacteria. The Verax Platelet PGD test is an immunoassay used on the day of transfusion at the point of care—a hospital or transfusion service—to quickly detect bacterial contamination in platelets and protect patients from receiving contaminated transfusions. The presence of bacteria in platelets can pose serious risks for patients, including sepsis—a life-threatening infection in the blood stream. The test is a more cost effective and less invasive approach to platelet bacterial safety than pathogen inactivation technologies.

The Verax Platelet PGD test is already used by many major U.S. cancer centers and children's hospitals to check two types of platelets: apheresis platelets in plasma (also known as single donor platelets, or SDPs) and whole blood derived platelets (WBDs). With this new FDA clearance, the Platelet PGD test can now be used as a Safety Measure to check two additional platelet types: pre-storage pool platelets (e,g, Acrodose™ platelets) and apheresis platelets in PAS-C additive solution and plasma.

Most health care facilities currently use single donor platelets (SDPs) or whole blood derived platelets (WBDs). As health care facilities expand their use of other platelet types, such as pre-storage pool platelets and apheresis platelets in PAS-C additive solution and plasma, today's FDA clearance means facilities will be able expand their use of the Verax Platelet PGD test to help reduce infectious risk to their patients.

The Verax Platelet PGD test was first cleared by the FDA in 2007 for detecting bacterial contamination in leukoreduced apheresis platelets and in 2009 for use with whole-blood derived platelets.

Verax's patented Pan Genera Detection (PGD) technology is based on the insight that recent advances in the field of immunotherapeutic agents can be used to develop tests to detect the broad array of bacteria in blood components. This broad detection is based on the existence of shared, or conserved, antigens that are common to the cell walls of the two broad classes of bacteria - Lipoteichoic Acids on Gram-positive bacteria and Lipopolysaccharides on Gram-negative bacteria. Verax targets these conserved Gram-positive and Gram-negative antigens to test biological samples for a broad range of bacterial contaminants by using pan genera binding agents to directly bind to these targets. This detection approach does not depend upon surrogate measures for bacterial presence or the measurement of byproducts of bacterial growth.

One major advantage of this approach is the large number of conserved antigens found on the cell surface of Gram-positive and Gram-negative bacteria. This provides a large number of detection events for a relatively small number of contaminating bacteria, which translates into the potential for a highly sensitive test system which is both simple and rapid to perform.